Review Pathway

The European Medicines Agency has recommended against EU marketing approval for two drugs targeting children.

Patients in the ICU continue to die from SARS-CoV-2-induced acute respiratory distress syndrome, says InflaRx, which is one of companies whose product the European Medicines Agency today announced should be approved for marketing in the EU.

After an initial rejection, the European Medicines Agency now says that Eisai/Biogen’s Alzheimer’s disease drug should be approved, albeit with a recommendation for initial generic screening and ongoing safety scans.

The European Medicines Agency’s human medicines committee is meeting this week due to decide whether or not to back pan-EU marketing approval for a number of new drugs.

Patient representatives are due to have their say today at a high-stakes meeting at the European Medicines Agency, which, after re-examining its previous rejection of Leqembi, is expected to deliver its final decision on whether the drug should be approved for marketing in the EU.

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Swissmedic has removed the requirement for companies to participate in accelerated application hearings in certain situations.

At the advisory committee review of Stealth’s Barth syndrome treatment elamipretide, Office of New Drugs Director Peter Stein clarified the circumstances where clinical data in a related indication could serve as confirmatory evidence for a single adequate and well-controlled study.

US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.

Manufacturers looking to change their device sterilization method as part of the move away from ethylene oxide (EtO) may be able to make use of the Predetermined Change Control Plan (PCCP) process, FDA officials said in a webinar this week.